Loading clinical trials...

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) | Clinical Trials | Clareo Health

COMPLETEDNA

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)

NCT05966662•Shockwave Medical, Inc.

View on ClinicalTrials.gov

Summary

This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Detailed Description

The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites. Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years. Each subject will be followed through discharge, 30 days, 6, and 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥18 years of age
•2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
•3. For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal)
•4. For subjects with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath
•1. If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal)
•2. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment
•5. Left ventricular ejection fraction \>25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure)
•6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
•7. Non-target lesions requiring PCI may be treated either
•1. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
+11 more criteria

Exclusion Criteria

•1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
•2. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
•3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
•4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
•5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
•6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin greater than 1 times the local laboratory's upper limit of normal
•7. New York Heart Association (NYHA) class III or IV heart failure
•8. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using CKD-EPI formula)
•9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
•10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
+17 more criteria

Locations (18)

Heart Center Research

Huntsville, Alabama, United States

Scripps Clinic

La Jolla, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Memorial Health

Hollywood, Florida, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Loyola University

Chicago, Illinois, United States

Norton Heart and Vascular Institute

Louisville, Kentucky, United States

Essentia Health St. Mary's Heart & Vascular Center

Duluth, Minnesota, United States

Washington University

St Louis, Missouri, United States

Northwell Health/Lenox Hill

New York, New York, United States

Key Dates

Start Date

December 8, 2023

Primary Completion Date

January 9, 2025

Completion Date

December 19, 2025

Last Updated

February 24, 2026

Enrollment

145

ACTUAL participants

Conditions

Coronary Artery DiseaseMyocardial Infarction

Interventions

IVL with Shockwave C2+ 2Hz Coronary IVL Catheter

DEVICE

Fast Discharge After Acute Myocardial Infarction Discharge MI

NCT06744322

Acute Myocardial Infarction (AMI)

View study

RECRUITINGPHASE2

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

NCT05198791

Myocardial Infarction, AcuteMyocardial Infarction With Nonobstructive Coronary Arteries+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

Inclusion Criteria

Exclusion Criteria

Fast Discharge After Acute Myocardial Infarction Discharge MI

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack

Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone

SuperSaturated Oxygen Comprehensive Observational Registry

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI